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EC number: 225-004-1 | CAS number: 4602-84-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Farnesol
- EC Number:
- 225-004-1
- EC Name:
- Farnesol
- Cas Number:
- 4602-84-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- farnesol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Individual housing (50 x 45 x 40 cm) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): Pellets with added vitamins, ad libitum
- Water (e.g. ad libitum): Drinking water for human consumption, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 C
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hour photoperiod with artificial lighting (120 lux)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days post application
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Clipped area (approximately 6 cm2) on the back of each test animal
- Type of wrap if used: Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), held in place by non-irritating tape (Elastoplast®, Beiersdorf AG, Hamburg) and Stuelpa® (P. Hartmann AG, Heidenheim-Brenz)
SCORING SYSTEM:
As per OECD Test Guideline 404
Erytrhema and eschar 0 -4 scale
Oedema 0-4 scale
Animals were examined for signs of erythema and oedema at 60 minutes and 24, 48 and 72 hours after patch removal and once daily thereafter up to 15 days post-application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Scale formation after 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Induration after 72 hours, scabbing after 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- other: Scale formation after 7 days
- Irritant / corrosive response data:
- Erythema (very slight to severe) was observed in all animals between 1 h after patch removal and day 7 post application (p.a.). It was still apparent in two animals on day 8 p.a. and in one animal up to the end of the observation period (day 15 p.a.). Oedema (very slight to severe) was observed in all animals up to day 6 p.a., and was still apparent in two animals up to day 11 p.a. and in one animal up to day 15 p.a.
Scale formation was seen from day 6 and day 7 p.a. up to the end of the observation period (day 15 p.a.) in animals no. 1 and 3, respectively.
Additionally, in one animal (no. 2) the treated skin area became indurated from 72 h and up to day 13 p.a. This induration was associated with fissures which were first bloody and then covered with scab. At the days 14 and 15 after patch removal the healing process caused an incipient desquamation of the indurated skin area .
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Mean individual values of 2.67, 2.67 and 2.0 were observed for erythema and mean individual values of 1.33, 3.0 and 2.33 were observed for oedema.
- Executive summary:
The test item was assessed in an acute dermal irritation/corrosion test in 3 albino rabbits. Shaved skin was exposed to 0.5 mL of the test article for 4 hours under a semi-occulsive dressing. Animals were examined for signs of erythema and oedema at 60 min, 24, 48 and 72 h after patch removal and thereafter once daily up to day 15 post application. Mean individual values of 2.67, 2.67 and 2.0 were observed for erythema and mean individual values of 1.33, 3.0 and 2.33 were observed for oedema. Very slight to severe erythema and oedema were observed in all animals. Additionally, scale formation was observed in two animals and in duration of the treated skin area with bloody fissures was seen in one animal. The effects in one animal were not fully reversible within 15 days after patch removal. This study is reliable without restrictions (Klimisch 1) as it was conducted according to relevant guidelines and GLP.
As mean values of ≥ 2.3 to ≤ 4.0 for erythema/eschar and oedema were observed in at least 2 of 3 tested animals, the test item is classified a Skin Irritant, Category 2.
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